(197 days)
Not Found
Not Found
No
The 510(k) summary describes a solid couplant membrane for ultrasound imaging, which is a passive material and does not involve any computational processing, let alone AI/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, performance studies, or metrics typically associated with AI/ML devices.
No
The device is described as a coupling agent for ultrasound imaging, facilitating the transmission of sound waves for diagnostic purposes, not for treating a condition.
No
The device, ScanFlex Solid Couplant Membranes, is described as intended for "coupling sound waves between the patient's body and medical imaging electronics" during diagnostic ultrasound imaging. It facilitates the imaging process but does not itself perform diagnosis or interpret diagnostic information.
No
The device description explicitly states "ScanFlex Solid Couplant Membrane," indicating a physical product, not software. The intended use also describes a physical membrane used for coupling sound waves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of ScanFlex Solid Couplant Membranes is to facilitate ultrasound imaging by coupling sound waves between the patient's body and the imaging equipment. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The description focuses on the physical function of coupling sound waves. The device acts as a physical interface for the ultrasound process, not as a diagnostic tool that analyzes biological markers or properties within a sample.
Therefore, ScanFlex Solid Couplant Membranes falls under the category of a medical device used in conjunction with diagnostic imaging, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.
Product codes
90 ITX
Device Description
ScanFlex Solid Couplant Membrane
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 5 1999
Margaret J. Larson President Sonotech, Inc. P.O. Box 2189 Bellingham, WA 98227-2189 RE:
K983691 ScanFlex Solid Couplant Membrane Dated: February 10, 1999 Received: April 6, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Larson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) NUMBER (IF KNOWN) : k 983691
DEVICE NAME : ScanFlex Solid Couplant Membrane
INDICATIONS FOR USE:
ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96
Stinid le. Segman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic 510(k) Number